Maintaining a Quality System in the Clinical Laboratory

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Whether considering the daily routine of bench work or the biennial survey of an inspection agency, a sound quality system is the bedrock of any laboratory operation. It is the evidence required to prove that on any given day, quality was properly addressed.

New platforms for the laboratory are becoming more sophisticated, lowering risk and aiding in the detection of errors, and allowing scientists to focus on other work. When errors do occur, they challenge the equilibrium of operations and staff.

How does a seasoned laboratory professional initiate steps toward a better quality system? Learning about the quality criteria and putting a quality management system in place is only the first step. According to Berte,¹ the following procedures must be implemented:

• Provide to staff only the latest approved versions of all documents
• Document and investigate every unexpected event and complaint; these events reveal problematic laboratory processes
• Validate every new or changed process before implementing it in the laboratory, whether or not it includes testing.

Little impact will be felt from implementing quality concepts without establishing a culture of quality as well. Even in the best-run organizations, one can expect push-back to following a quality system, more so when the system is particularly rigorous. In any organization concerned with cost overruns, QC is often mistakenly seen as having the least tangible benefit. When faced with a stressful environment that values production over quality, staff may delay or eliminate quality protocols, deeming them unnecessary. Changing a culture to one of quality requires leadership commitment, education, and employee empowerment to allow the laboratory to rise to its greatest potential.

Cost of poor quality

Financial savings can provide proof of the quality program’s efficacy and consequently more support. “One way a lab can do this is to calculate Cost of Poor Quality (CoPQ) as a baseline metric. CoPQ includes financial losses associated with rework and any costs incurred because something performed poorly the first time. CoPQ represents cost savings and cost avoidance, which contributes to the lab’s bottom line.”²

As an illustration of cost avoidance, consider the immunoassay troponin I (cTnI). If a patient suffers a cardiac event and is admitted to an emergency room, results of cardiac enzymes must be attained as quickly as possible. Results from the first troponin test help doctors gauge the likelihood of hospital admission versus discharge; if the former is chosen, the test result guides early inpatient care.³

As platform manufacturers have continued to improve the sensitivity, specificity, and level of detection of the cTnI assay, it has become critical to tightly monitor the performance of the assay via use of high-performance immunoassay quality control materials. Accurate test results have an immediate impact on a patient’s life, the care he or she receives, and the disposition of healthcare resources employed. The ramifications of unnecessarily holding a patient thought to have myocardial infarction in the critical-care unit are significant due to the downstream cost of an error in diagnosis. Misdiagnoses and misappropriations of resources should never happen, and poor-quality laboratory results should never be the cause of such an error.

Verify test quality

Liquichek Immunoassay Plus Quality Control (Bio-Rad Laboratories, Hercules, CA)

Procalcitonin (PCT) is an immunoassay test that has grown quickly in its importance and utility in the acute-care setting as a biomarker for the detection of sepsis. Early detection, diagnosis, and treatment are key to patient survival rates.⁴ A large body of evidence supports the use of PCT and lactic acid to differentiate bacterial from viral or noninfective diagnoses, to help risk-stratify patients, and to guide antibiotic therapy decisions about initial need for, and optimal duration of, therapy.^5,6 For those institutions adopting the guidelines to test for PCT upon ICU admission with suspected or documented sepsis, producing an accurate result becomes critical to lowering hospital and ICU length of stay⁷ and decreasing the total cost of septicemia hospitalization. The only way to know if a patient’s PCT results are reliable is to run quality control at the recommended intervals and compare the results to the established QC ranges.

Inventory management

A final facet of improving the quality system is to take a look at inventory management. In “10 Trials of Lab Quality,” Dawson asked, “Has your lab ever run out of reagents, causing a delay in turnaround time? Have you ever run out of critical supplies? How frequently is your lab paying for overnight shipping due to a shortage in reagents or supplies?”⁸ The answer to all of these potential pitfalls is consistent inventory management. Appropriate steps to improve inventory management include:

• Assess the lab’s daily routine and pay close attention to stock levels. Items that are used daily—such as bench consumables like transfer pipets, quality control materials, and reagents—are at the highest risk of being depleted. In a just-in-time purchasing environment, strict surveillance of stock levels is crucial. Established manufacturers know that laboratories must adhere to cost-containment protocols and will request shipment of inventory as needed.
• Assign teams to monitor inventory levels of reagents needed for their department.
• Be cognizant of storage capacity, particularly refrigerator space. Establishing minimum thresholds for ordering, and placing orders with consideration to documented usage, rather than continually purchasing in excess, may save money as well as space.

Summary

Communication, collaboration, and thorough preparation are essential to developing a quality system. In the healthcare delivery process, a consistent and thoughtful approach to quality will benefit the clinician and ultimately the patient.

References

1. Berte, L.M. Living in quality. Lab Medicine 2009, 4(6), 330.
2. Dawson, J. Quality from the ground up. Critical Values Jan 2017, 10(1), 22–5.
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415742
4. Weissman, A. The laboratory’s role in combating sepsis. Med. Lab. Observer June 2016, 48(6), 18.
5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3520973
6. Feinstein, D. The drive to standardize clinical practice for sepsis. Med. Lab. Observer Sept 2016, 47(9), 41.
7. Balk, R.A.; Kadri, S.S. et al. Effect of procalcitonin testing on health-care utilization and costs in critically ill patients in the United States. Chest Jan 2017, 151(1), 23–33.
8. http://laboratory-manager.advanceweb.com/10-trials-of-lab-quality

Ginger Weeden MLS (ASCP)cm is a 30-year professional in clinical laboratory science; e-mail: [email protected]